Shots:
- TULIP-SC full results reinforce efficacy and remission potential with subcutaneous Saphnelo, showing higher disease activity reduction (56.2% vs 34% placebo at Week 52), improved BICLA response, DORIS-defined remission, and reduced oral corticosteroid use, consistent with the IV formulation
- Self-administration expands access and adherence, offering flexible at-home or clinic dosing, supporting earlier biologic intervention and steroid minimization, while maintaining safety and improving patient experience
- PharmaShots welcomes Caterina Brindicci, Senior Vice President & Global Head Research and Development, Respiratory & Immunology, AstraZeneca, for an engaging conversation on the future of lupus care and self-administered biologics
Saurabh: Congratulations on the publication of the TULIP-SC full results! Could you share your high-level takeaways on how these data advance the case for Saphnelo self-administration in moderate to severe SLE, especially compared with existing administration routes?
Caterina: Thank you! We are proud to see the TULIP-SC data published in Arthritis & Rheumatology demonstrating the efficacy and remission rates of Saphnelo self-administration.
With existing administration routes, only 1 in 5 patients with Systemic Lupus Erythematosus (SLE) currently receive a biologic, so subcutaneous Saphnelo has significant potential to drive impact for patients. Notably, the TULIP-SC results are clinically meaningful and provide confidence that the efficacy and DORIS-defined remission rates that we have previously seen with Saphnelo IV can be achieved in a new subcutaneous administration.
Self-administration of Saphnelo could also offer greater flexibility and convenience to a wider group of patients who will have the option to receive treatment at home or in the clinic. Subcutaneous Saphnelo enabled more patients to achieve DORIS remission (the recommended definition of remission in SLE care), more patients experienced reduced disease activity (BICLA) and were able to reduce their use of oral corticosteroids (OCS) versus placebo.
Saurabh: The TULIP-SC trial showed a statistically significant and clinically meaningful reduction in disease activity with weekly subcutaneous dosing (56.2% vs 34% placebo at Week 52). How do you interpret this magnitude of effect in the real-world context of SLE management?
Caterina: In today’s world, we have treatments with the potential to reduce long-term organ damage compared to standard of care, but due to delays in diagnosis and limited access to treatments, remission is currently achieved in fewer than 10% of people with SLE. Evidence from across clinical trials and real-world studies have shown that remission is an achievable goal with Saphnelo. The new Saphnelo subcutaneous administration method offers the potential for even more patients to achieve the clinically meaningful benefits of the treatment with greater flexibility and convenience. The results align with important changes in global lupus treatment recommendations, which now emphasise earlier intervention with biologics, driving remission and reduced use of oral corticosteroids as key treatment goals.
Saurabh: In your view, does this self-administration broaden the clinical utility of anifrolumab for patients earlier in their disease journey or those reluctant to pursue IV infusions?
Caterina: Yes, absolutely. Subcutaneous Saphnelo will extend the treatment’s reach by allowing healthcare providers to offer clinically meaningful benefits to a broader group of SLE patients in a more flexible and convenient way. This will include SLE patients early in their disease journey and patients who are reluctant to pursue IV infusions.
Saurabh: Convenience and flexibility are often cited as benefits of subcutaneous therapies. How do you expect the TULIP-SC data to shift the patient experience and adherence landscape in lupus care?
Caterina: Patients with SLE face an incredible burden managing the day-to-day needs of this disease, with some patients traveling long distances and taking time away from family and work to receive their medication in a physician’s office. Subcutaneous administration offers patients a more flexible and convenient way to achieve DORIS-defined remission rates and clinically meaningful effects across a range of outcome measures.
In the TULIP-SC study, patients who experienced reduced disease activity (BICLA) on subcutaneous Saphnelo were also able to reduce their use of oral corticosteroids (OCS) versus placebo. This is a key treatment goal and aligns with important changes in global lupus treatment recommendations.
We believe that supporting patient choice, in collaboration with healthcare professionals, is essential to achieving optimal outcomes in SLE, as it enables patients to select therapies that best suit their individual needs and lifestyles.
Saurabh: What are the key educational or support considerations for patients transitioning to self-administration, both from a clinical team perspective and patient lifestyle standpoint?
Caterina: The efficacy and safety data in the TULIP-SC trial are consistent with the known clinical profile of Saphnelo administered as IV. Subcutaneous Saphnelo was well tolerated, and the frequency of overall adverse events was balanced between the Saphnelo and placebo treatment groups. Patients transitioning to self-administration should not experience a change in therapeutic effect but can expect more flexibility in how they receive care.
Patients should always work with their rheumatologist when making treatment decisions.
Saurabh: The broader TULIP-SC analyses suggest benefits in achieving DORIS-defined remission and lowering steroid reliance. How do these findings align with evolving treatment goals in SLE, for example, minimizing organ damage risk and long-term corticosteroid exposure?
Caterina: The TULIP-SC findings build on the established profile of Saphnelo, which has helped patients achieve remission and significantly reduce reliance on oral corticosteroids – further reinforcing our ambition to transform lupus care.
These results are in line with the recent paradigm shift in treatment guidelines and recommendations, including recent updates from the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR), which now emphasise the importance of reduced oral corticosteroid use and earlier intervention with biologics to reinforce remission as a key treatment goal.
Saurabh: Looking ahead, are there additional indications or patient populations where you see self-administered anifrolumab making a meaningful impact?
Caterina: At AstraZeneca, our bold ambition is to transform the care of immune-mediated diseases for patients by moving beyond symptom control to long-term remission, and one day, cure.
In active Phase 3 studies, we are evaluating the potential of anifrolumab in diseases where type 1 interferon plays a key role and have studies in cutaneous lupus erythematosus, myositis, systemic sclerosis, and lupus nephritis.
Saurabh: The EU has recently approved the subcutaneous Saphnelo formulation, and regulatory reviews are ongoing globally. From your vantage point, what will be critical in shaping regulatory confidence and payer access for self-administration worldwide?
Caterina: Regulators in other markets will be looking for confidence that the efficacy and DORIS-defined remission rates that we’ve seen with Saphnelo IV can be achieved in a new subcutaneous administration whilst maintaining the established safety profile. The TULIP-SC data provides this reassurance. Upon regulatory approval, markets will file for reimbursement of subcutaneous anifrolumab.
Saurabh: What is the “one key message” you want clinicians and patients to take away from the newly published TULIP-SC results regarding the future of lupus care?
Caterina: The TULIP-SC results are clinically meaningful and provide confidence that the efficacy and DORIS-defined remission rates that we have seen with Saphnelo IV can be achieved in a new subcutaneous administration.
About the Author:
Caterina Brindicci
Senior Vice President & Global Head Research and Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca
As Senior Vice President & Global Head Research and Development, Respiratory & Immunology, Caterina Brindicci works end-to-end from pre-clinical discovery research through to Phase III, regulatory submission, approval, and subsequently into life cycle management. Caterina leads a global team of +900 inspirational scientists, clinicians, biometrics experts, and regulatory affairs specialists.
Caterina is a Respiratory Physician, holding a PhD in clinical pharmacology and molecular biology from Imperial College London and an MBA from Bocconi University.
Caterina plays a pivotal role in AstraZeneca’s BioPharmaceuticals R&D Leadership Team and holds +15 years of experience in senior roles across the pharmaceutical industry. Prior to joining industry, Caterina worked as a Pulmonologist at the National Heart & Lung Institute and Royal Brompton Hospital.
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